Galderma: FDA Approval for Nemluvio®
Today, August 13, 2024, Galderma (GALD.SW) announced that the U.S. FDA has approved its product Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis.
Galderma exists in approximately 90 countries. It delivers an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.
Since its foundation in 1981, Galderma dedicated its focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.
Galderma has stated that because it understands that the skin of each individual person is unique, it is “advancing dermatology for every skin story”.
About Nemluvio®
Nemluvio® (nemolizumab-ilto) was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.
Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
About Prurigo Nodularis
Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.
Prurigo nodularis is an underdiagnosed neuroimmune skin disease. It is estimated to affect up to 181,000 people in the United States. Given the significant burden on patients, there is a need for alternative treatment options that may effectively relieve key signs and symptoms of the disease.
From Galderma
Flemming ørnskov, M.D., MPH Chief Executive Officer Galderma said, “The U.S. FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases shortly.”
Phase III OLYMPIA 1 and OLYMPIA 2 clinical trials: These trials have evaluated the efficacy and safety of Nemluvio, which is administered subcutaneously every four weeks in more than 500 patients with prurigo nodularis. The trials met both their primary endpoints and key secondary endpoints. They demonstrate that:
- 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in itch intensity at Week 16, as measured by the peak-pruritus numerical rating scale, compared to 16% in both placebo groups. (primary endpoint).
- 41% of Nemluvio-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (key secondary endpoint).
- 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, reached clearance (investigator’s global assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (primary endpoint).
- 50% and 52% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in sleep disturbance at Week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (key secondary endpoint).
The trials met all other key secondary endpoints, confirming the rapid reduction of itch and sleep disturbance caused by prurigo nodularis, within four weeks of treatment initiation. Nemluvio was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.
More from the Experts
Joseph W. Burnett Endowed Professor and Chairman of Dermatology University of Maryland School of Medicine said, “I’m delighted that Nemluvio has received U.S. FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life. By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”
Galderma’s marketing authorization applications for Nemluvio in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework.
Further submissions to other regulatory authorities will continue throughout 2024.
Indication: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used to treat adults with prurigo nodularis.
People should not take Nemluvio if they are allergic to nemolizumab-ilto or any ingredients in this product.
Before taking NEMLUVIO, patients must tell their healthcare provider about all of their medical conditions, including if they are scheduled to receive any vaccination. They should not receive a live vaccine right before or during treatment with NEMLUVIO, and they should not take the drug if they are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.
- It is not known whether NEMLUVIO will harm unborn babies.
- It is not known whether NEMLUVIO passes into the breast milk or whether it can harm the baby.
- Patients must tell their doctors about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Nemluvio may cause serious side effects, including, allergic reactions.
Patients must Stop using NEMLUVIO and tell their healthcare provider or get help right away if they get any of the following symptoms:
- Breathing problems; Wheezing; Swelling of the face, lips, mouth, tongue, or throat; Fainting; dizziness; Feeling lightheaded; Having fast pulse; Swollen lymph nodes; Joint pain; Fever; Skin rash, red, rough skin); Nausea or vomiting; General ill feeling; Cramps in stomach area
The most common side effects of NEMLUVIO include:
- Headache, Skin rash, eczema, atopic dermatitis (a type of eczema), and/or, eczema nummular (eczema presenting as scattered circular patches). These are not all of the possible side effects of NEMLUVIO.
Patients must call their doctors for medical advice about any side effects and may also report side effects to the FDA at 1-800-FDA-1088.
Please see the full prescribing information, including Patient Information.
About Phase III Olympia Clinical Trial Program
The OLYMPIA program included two identically designed, pivotal phase III clinical trials that enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. The global randomized double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.
For more information about Golderma: www.galderma.com.
Prohost Observation
We are happy to learn about Galderma and we appreciate the U.S. FDA’s approval of its product Nemluvio® (nemolizumab) that treats adult patients who are living with prurigo nodularis.
News & Comments
August 13, 2024
Galderma Receives U.S. FDA Approval for Nemluvio® for Adult Patients with Prurigo Nodularis
Galderma: FDA Approval for Nemluvio®
Today, August 13, 2024, Galderma (GALD.SW) announced that the U.S. FDA has approved its product Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis.
Galderma exists in approximately 90 countries. It delivers an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.
Since its foundation in 1981, Galderma dedicated its focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.
Galderma has stated that because it understands that the skin of each individual person is unique, it is “advancing dermatology for every skin story”.
About Nemluvio®
Nemluvio® (nemolizumab-ilto) was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.
Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
About Prurigo Nodularis
Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.
Prurigo nodularis is an underdiagnosed neuroimmune skin disease. It is estimated to affect up to 181,000 people in the United States. Given the significant burden on patients, there is a need for alternative treatment options that may effectively relieve key signs and symptoms of the disease.
From Galderma
Flemming ørnskov, M.D., MPH Chief Executive Officer Galderma said, “The U.S. FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases shortly.”
Phase III OLYMPIA 1 and OLYMPIA 2 clinical trials: These trials have evaluated the efficacy and safety of Nemluvio, which is administered subcutaneously every four weeks in more than 500 patients with prurigo nodularis. The trials met both their primary endpoints and key secondary endpoints. They demonstrate that:
The trials met all other key secondary endpoints, confirming the rapid reduction of itch and sleep disturbance caused by prurigo nodularis, within four weeks of treatment initiation. Nemluvio was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.
More from the Experts
Joseph W. Burnett Endowed Professor and Chairman of Dermatology University of Maryland School of Medicine said, “I’m delighted that Nemluvio has received U.S. FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life. By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”
Galderma’s marketing authorization applications for Nemluvio in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework.
Further submissions to other regulatory authorities will continue throughout 2024.
Indication: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used to treat adults with prurigo nodularis.
People should not take Nemluvio if they are allergic to nemolizumab-ilto or any ingredients in this product.
Before taking NEMLUVIO, patients must tell their healthcare provider about all of their medical conditions, including if they are scheduled to receive any vaccination. They should not receive a live vaccine right before or during treatment with NEMLUVIO, and they should not take the drug if they are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.
Patients must Stop using NEMLUVIO and tell their healthcare provider or get help right away if they get any of the following symptoms:
The most common side effects of NEMLUVIO include:
Patients must call their doctors for medical advice about any side effects and may also report side effects to the FDA at 1-800-FDA-1088.
Please see the full prescribing information, including Patient Information.
About Phase III Olympia Clinical Trial Program
The OLYMPIA program included two identically designed, pivotal phase III clinical trials that enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. The global randomized double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.
For more information about Golderma: www.galderma.com.
Prohost Observation
We are happy to learn about Galderma and we appreciate the U.S. FDA’s approval of its product Nemluvio® (nemolizumab) that treats adult patients who are living with prurigo nodularis.
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